The present invention relates to a tamper evident protector overcap for a pre-filled syringe barrel. More particularly, the invention relates to a cap for a syringe barrel containing a liquid medication therein for securely holding a closure in the tapered tip of the syringe barrel and serving as a tamper evident indicator.
Pre-filled syringe barrels or cartridges containing injectable solutions therein are stoppered by elastomeric closures, such as soft rubber stoppers at the distal, tapered end thereof, while the proximal end of the barrels are closed by slidable plungers. The pre-filled syringe barrels or cartridges are sterilized, such as by autoclaving, and packaged ready for use.
It has been observed that during in-line processing, handling, and sterilizing of the pre-filled barrels, some polymeric or elastomeric closures were missing from the tips of the barrels resulting in rejects. Also, during shipment of the finished product and handling by healthcare professionals some untipped barrels were observed which necessitated discarding of batches containing failed samples. For product integrity a corrective measure was indicated to prevent the polymeric or elastomeric closure from becoming dislodged from the tip of the barrel.
More importantly, it has also been recognized that untipped barrels, whether the damage occurred during shipment or handling, attracts the suspicion that the product was tampered with. Such possible tampering is a concern for both the National Regulating Authorities and the manufacturers who are required to insure safety, efficacy and the product integrity.
The prior art has provided various tamper evident closures for syringes.
For example, tamper evident syringes may be characterized in that the syringe barrel, the cap, and the plunger rod are covered with a tubular sealing device that is made from a heat-shrinkable film and which has been shrunk under heat so that it adheres closely to the surfaces of those members. The sealing device comprises a tube and a tear tape. The tube is formed of a transparent heat-shrinkable film. The tear tape is attached by bonding to the inner surface of the tube from one end to the other in the longitudinal direction.
Another example is a hypodermic syringe used with a needle for lyophilized medicament comprising: a syringe body having a piston therein equipped with a tip cap at its distal end; an elastomeric plug having a passage channel closing the neck of the syringe; and a protector cap which encloses the tip cap and the neck portion of the syringe body. The protector cap and tip cap are integral with each other and can be moved axially to open and close the syringe. The protector cap consists of a top portion and a bottom portion, the two parts being held together by a weakened portion. The center of the protector cap is provided with a small hole through which the tip cap can be viewed. In use, the top portion of the protector cap is snapped off at the weakened portion, and the tip cap is taken off and discarded. A needle is then fitted in the passage channel of the elastomeric plug to access the content of the syringe.
Still another example is discloses a syringe cap assembly placed on the distal end of a syringe. The assembly includes: an elastomeric insert having a passage therein; a retaining collar which fits over the elastomeric insert to hold the insert in place; a plug or tip cap is engaged in the insert to block the passage in the insert; and a retaining safety cap fitted over the tip cap. The end wall of the retaining safety cap is formed with a hole in its center and is slightly smaller in diameter than the plug so that the user can ascertain that the plug is properly in its place without opening the assembly.
In use the safety cap is pulled, twisted, and lifted off the assembly. The plug is then lifted off to expose the collar, and a needle assembly is fitted to the collar.
A further example is a pre-filled syringe with break-away tip seal which closes the passageway to the content of the syringe. A score means is provided adjacent to the tip for accommodating removal of the sealed tip.
An object of the present invention is to provide a pre-filled tamper evident syringe or cartridge barrel which makes apparent the unauthorized use of the medical fluid contained in the barrel of the syringe or cartridge or at least warns healthcare professionals that such unauthorized use may have occurred.
Another object of the present invention is to provide tamper evident syringe or cartridge barrels the content of which is easily accessed by the healthcare professionals while their unauthorized use is readily apparent.
A further object of the present invention is to provide a tamper evident syringe or cartridge barrel the content of which can be accessed by luer connections or a tubing conduit so as to avoid the use of xe2x80x9csharpsxe2x80x9d and thereby preventing needle stick injuries.
In accordance with the present invention, an overcap is provided for a syringe or cartridge barrel containing a pharmaceutical or biological liquid. The overcap is designed to indicate unauthorized use of the content of the syringe or cartridge barrel.
The pre-filled syringe or cartridge barrel terminates in a tapered tip having a bore therethrough. The tapered tip is equipped with a female luer connector to which a male luer connector or an injection needle may be attached. The bore in the tapered tip is stoppered by an elastomeric stopper, such as a soft rubber plug. At the base of the tapered tip above the shoulder of the syringe or cartridge barrel two protuberances or knobs are provided for engagement with cut-outs or notches in the overcap. A ring above the protuberances or knobs on the tapered tip serves to allow the overcap to turn in clockwise or counter-clockwise directions prior to disengaging the overcap from the syringe or cartridge barrel. The overcap covering the tapered tip comprises: a cylindrical top portion; and a cylindrical bottom portion. The cylindrical top and bottom portion may have the same diameter, or the bottom portion may have a slightly larger diameter than the top portion.
The top and bottom portions of the overcap are connected by a frangible area allowing the top portion to be removed from the bottom portion. The bottom portion in both embodiments is provided with cut-outs or notches designed to engage the protuberance or knobs on the distal end of the syringe or cartridge barrel.
In use, the healthcare practitioner depresses the overcap toward the barrel so that cut-outs or notches in the first embodiment, or cut-outs or notches in the second embodiment engage protuberances or knobs on the distal end of the barrel. Holding on to the top portion the overcap is twisted in clockwise or counter-clockwise direction so that the top portion is separated from the bottom portion at the frangible area between the top and bottom portions. The top portion is discarded while the bottom portion of the overcap remains on the distal end of the barrel. Next, the resilient closure is removed exposing the female luer connector to which a male luer connector or a syringe is attached for removal of the content of the barrel.
Separation of the top portion of the overcap from the bottom portion thereof prior to use indicates evidence to the healthcare professional that the product may have been tampered with and should not be used.